Physical Design Engineer

Join us as a Risk Management Champion! Lead the creation of high-quality global Risk Management Plans and reports, drive process improvements, and ensure Health Authority comments are addressed. Collaborate with cross-functional teams and harmonize best practices across Therapeutic Areas. Make a difference with Novartis!

Major accountabilities :

1. Lead the authoring, review, and independent management of Safety Concerns and other critical content in Risk Management Plans (RMPs) and other aggregate reports; prepare initial RMPs and updates for new products, acquisitions, or indications.
2. Review and ensure HA comments are addressed in all relevant deliverables across departments, collaborating with medical, QPPV, and global stakeholders.
3. Contribute to data analysis planning and presentation, including statistical analysis plan reviews, and develop strategies for RMP submissions.
4. Participate in complex cross-functional global projects focusing on quality improvement, including IT projects involving AI and automation.
5. Provide expertise in developing safety document templates and SOPs to ensure compliance with worldwide regulations.
6. Assess the impact of updates to PV regulatory requirements, develop training materials, conduct workshops, and mentor junior staff to build a pool of SMEs.
7. Serve as a consultant for cross-functional teams and external providers involved in report preparation.
8. Support the Team Lead / Group Head in recruitment and act as a deputy when needed.

Essential Requirements :

1. Graduate/Postgraduate/Doctorate in Life Sciences, Pharmacy, Medical Sciences, or equivalent.
2. Minimum 7 years’ experience in drug safety/development, with at least 5 years in safety writing.
3. Fluent in English; Spanish knowledge is an advantage.
4. Strong understanding of disease areas, drug development, GCP, and medical terminology.
5. Expertise in data analysis, project management, and leading global teams.

You will receive :

Benefits include those outlined in the Novartis Life Handbook, plus standard benefits like pension, insurance, meals allowance, and flexible hours.

Commitment to Diversity and Inclusion :

Novartis aims to foster an inclusive, diverse work environment reflecting the communities we serve.

Accessibility and accommodation :

We provide reasonable accommodations for individuals with medical conditions or disabilities. Contact us via email with your request and contact details, including the job requisition number.